Effectiveness and safety of Xinkeshu on coronary artery disease patients combined with anxiety and depression symptoms after percutaneous coronary intervention: A protocol for systematic review and meta-analysis

Background: It's known that coronary heart disease (CHD) patients after percutaneous coronary intervention (PCI) was significantly associated with anxiety and depression symptoms. Several studies have showed that Xinkeshu tablet (XKS), a kind of Chinese herbal medicine, could effectively improve post-PCI postoperative mood disorders in CHD patients. However, the intensity of evidence has been poor, limiting the further clinical application of XKS to patients above. This systematic review and meta-analysis will assess the effectiveness and safety of studies of XKS in CHD patients with anxiety and depression symptoms after PCI.

Methods: A systematic literature search for articles up to December 2021 will be performed in following electronic databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database Database, Chinese Biomedical Database, Chinese Biomedical Literature Service System, and Wanfang Database. Inclusion criteria are randomized controlled trials of XKS applied on patients with CHD and depression. The primary outcome measures will be CHD-related clinical evaluation (frequency of acute attack angina, severity of angina pectoris, electrocardiographic changes, amount of nitroglycerin) and the scores or reducing fractions of depressive and anxiety measuring scales (the Hospital Anxiety/Depression Scale or other widely used anxiety/depression scale). The safety outcome measures will be adverse events, liver and kidney function. RevMan 5.3 software will be used for data synthesis, sensitivity analysis, subgroup analysis, and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias. Stata 12.0 will be used for meta-regression and Egger tests. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence.

Discussion: This study will provide a high-quality synthesis of the effects and safety of XKS for CHD patients with anxiety and depression symptoms after PCI.

Ethics and dissemination: This systematic review does not require ethics approval and will be submitted to a peer-reviewed journal.Trial registration number PROSPERO CRD42019131346.